Assessment of Pain Management After Orthognathic Surgery by the Administration of Montelukast: An Original Research

ABSTRACT

Introduction:

Opioid may cause undue risk after surgical procedures like orthognathic surgeries. The present study was aimed to determine how the preoperative administration of oral montelukast affected the degree of postoperative discomfort following bimaxillary orthognathic surgery (BOS).

Methodology:

This study included all skeletal class III subjects scheduled for BOS. The participants were split into placebo and montelukast groups at random. Every patient received a 10-mL serving of apple juice an hour prior to the surgery; however, for the intervention group, a montelukast 10 mg pill was dissolved in the juice. The same surgical team and general anesthetic guidelines were used for all procedures. The visual analog scale (VAS) was used to calculate postoperative pain at designated intervals. The significance level for the statistical analysis was determined using the Statistical Package for the Social Sciences (SPSS) version 23.

Results:

The control subjects had a higher level of pain at all the intervals than the intended drug test group. Also, the control group needed more analgesics than the test group. There was one observation made that the length of the surgery had an impact on the postoperative pain.

Conclusion:

Preoperative montelukast medication may be useful in minimizing postoperative discomfort following bimaxillary orthognathic surgery. More research is required for greater relevance.

INTRODUCTION

Orthognathic procedures are regarded as the cornerstone of treatment for addressing complex malocclusions, jaw discrepancies, and for preserving a proper and stable dentoskeletal connection.[1,2] The most common causes of patient discomfort are mainly postoperative pain and edema.[1,3,4] The initial postsurgical phase is usually marked by moderate-to-severe discomfort. Osteotomies, muscle stripping, and tissue manipulation all lead to this pain.[1,3,4] Therefore, it appears that using pharmaceutical analgesic therapies to lessen postoperative pain is of highest relevance.[5] Opioids are frequently given for managing moderate-to-severe pain after surgical operations because of their central effects. The effectiveness of adjuvant non-opioid analgesics in minimizing postoperative pain has also been demonstrated.[3,5] Because of the risks of opioid use, they should be given wisely and carefully. They may also lead to many other postoperative complications due to “postoperative nausea and vomiting (PONV)”. Additionally, since patients undergoing orthognathic surgery have the devices implanted like wires, these drugs need to be administered with caution. A specific antagonist of the “cysteinyl leukotriene receptor” is montelukast. The lipid inflammatory mediators called leukotriene is created when arachidonic acid is oxidized by the enzyme lipoxygenase.[6–8] Its antagonists are frequently used to treat diseases like asthma, sinusitis, and allergic rhinitis because they reduce leukotriene production.[6–9] Additionally, this medicine is highly useful in reducing pain following interventional surgical operations.[6–8,10,11]

The degree of discomfort experienced after orthognathic surgery may be influenced, according to the authors’ hypothesis, by oral montelukast premedication. To the best of our knowledge, no research has been done on this subject in people who have had orthognathic surgery.[5–7,10] Therefore, the present study aimed to determine how preoperative administration of oral montelukast affected the degree of postoperative discomfort following bimaxillary orthognathic surgery.

MATERIAL AND METHODS

A clinical trial was conducted after thorough randomization of 40 subjects who were grouped as test and controls. This study adhered to the CONSORT statements and the Declaration of Helsinki. Only after receiving completely informed and written consent were patients enrolled. The study was conducted for a period of one year. Participants with skeletal class III deformities who were healthy and were between the ages of 18 and 45 years were recruited for the study. The bimaxillary orthognathic surgery (BOS) was performed among all the subjects. Oral montelukast was given to the test arm before the surgery was performed. Subjects who were on pain killers or other medications; with medical conditions; or not consenting to the study were excluded from the study. The standard procedure was followed for the BOS. Postoperative care was taken as per the protocol. Care was taken to avoid the opioids after the surgery. All the operations were carried uneventfully.

For the present study, the 10-cm visual analog scale (VAS), which is marked with numbers from 0 to 10, is a common and accepted way to gauge pain intensity following surgery. Soon after the surgery, the pain was calculated at every three hours for 24 hours. This was done by a resident who was blinded.

Along with the demographics, the duration of the operation and the pain scores were noted and analyzed using the Chi-squared test. For the descriptive analysis, the central tendency and dispersion indices were displayed using the relevant charts and tables. Using the Statistical Package for the Social Sciences (SPSS) version 23, a P value < 0.05 was taken as significant.

RESULTS

The mean age was 25 ± 0.5 years, and the male-to-female ratio was 1.1:1. In both the groups, a similar distribution was seen. The mean duration of the surgery was 190.0 ± 11.0 min. The duration for the surgery was almost similar in both the groups. Care was taken such that there was no significant difference in the subjects’ characteristics [Table 1].

Table 1.

Comparison of the subjects’ characteristics

Feature	Group	n	Mean±SD	P
Age	Test	20	25±0.5	NS
	Control	20	25±0.5
Duration of the surgery (minutes)	Test	20	191.0±11.0	NS
	Control	20	190.1±12.0
Male-to-female ratio	Test	20	1.1:1	NS
	Control	20	1.09:1

Comparisons were also made for postoperative pain in both the groups at the designated time intervals. It was noted that there was a significant difference between the test and the control groups for all the timelines. The VAS was different to a greater extent as the time progressed at the beginning of post -ope period as shown in Table 2.

Table 2.

Comparison of the VAS scores after surgery for both arms

Feature	Group	n	Mean±SD	P
Postoperative pain after 1 h	Test	20	3.3±0.5	0.02
	Control	20	4.1±0.4
Postoperative pain after 3 h	Test	20	3.4±0.5	<0.01
	Control	20	4.2±0.5
Postoperative pain after 6 h	Test	20	4.1±0.6	<0.01
	Control	20	5.1±0.4
Postoperative pain after 9 h	Test	20	4.5±0.5	<0.01
	Control	20	5.6±0.4
Postoperative pain after 12 h	Test	20	3.6±0.2	<0.01
	Control	20	4.5±0.5
Postoperative pain after 24 h	Test	20	3.5±0.1	<0.01
	Control	20	4.4±0.2

The association of the duration of the surgery and the postoperative pain were evaluated in the present study. It was seen that there was a direct relationship between the duration and the pain. If the surgery was longer in duration, there was greater postoperative pain. In the present study, the control group had a longer duration of the surgery than the test group; however, the difference was insignificant [Table 3].

Table 3.

Correlation between time and the VAS

Arms	Relation	Time for the Surgery
Test	Pearson correlation coefficient	0.641
	P	<0.001
Control	Pearson correlation coefficient	0.734
	P	<0.001

DISCUSSION

In this study, the impact of preoperative administration of oral montelukast on class III patients’ post-orthognathic pain levels was assessed.

After orthognathic surgery, moderate-to-severe discomfort is not uncommon.[1,2,4] The postoperative administration of opioids and non-steroidal anti-inflammatory drugs (NSAIDs) constitutes the traditional analgesic therapy.[1–4,12] Opioids have been known responsible for the Post Operative Nausea and Vomiting in numerous investigations. PONV is significantly linked to dangerous and even fatal consequences. Particularly at risk for aspiration of stomach contents are patients who have intermaxillary fixation and have undergone orthognathic surgery.[1–5,12–14]

The pain initially increased and later reduced after 12 hours and as the days progressed to the second day the pain was relatively stable. When compared to the placebo group across all time intervals, the montelukast group experienced much less discomfort. A specific cysteinyl leukotriene antagonist, montelukast was administered in this group.[6,15] This randomized clinical trial involved 40 consecutive participants in total. The sample size of the present study was comparable to those by Wilson et al.,[9] Schaper et al.,[12] Mostafa et al.,[16] and Ince et al.[6] However, the surgeries were performed in cases for nasal polyp, tonsillectomies, and asthma. In their studies, they evaluated pain using the VAS and the drug considered was oral montelukast.

The study by Samieirad et al.[3] and Fujiwara et al.[11] evaluated the VAS after administration of oral montelukast at intervals of two hours. The findings of the present study were similar to their studies. In the present study, the dosage of oral montelukast that was given was 10 mg. These dosages were comparable to the studies by Schaper et al.,[12] Wilson et al.,[9] and Mostafa et al.[16]

The postoperative VAS results in this study when the oral montelukast was given were comparable to drugs like rescue analgesic morphine, Apotel, diclofenac, and dexamethasone.[1,3,17]

Despite the temporal intervals, the placebo group consistently outperformed the montelukast group in terms of pain scores (P < 0.05 for all periods). Additionally, the placebo group experienced more general discomfort on average than the montelukast group (P < 0.001). It has been demonstrated that montelukast effectively lessens discomfort in sufferers of dysmenorrhea, as well as other conditions.[6–20] This drug has been shown to effectively lessen pain in COVID patients.[19] Montelukast improved both the airflow restriction and the nasal symptom score. It lowers the mediators of inflammation.

It is significant to highlight that the drug montelukast’s mechanism of action can be utilized to explain how it can lessen pain in those who have not responded to treatment. The current investigation’s findings were consistent with this significant disparity in the demand for opioid administration. If taken for a long term, it may have side effects. However, taking one dose of montelukast has no discernible side effects. The research indicates that a single oral dose of montelukast (10 mg) has no obvious interactions with the effectiveness of steroids.[6,8,9,16,17] Ince et al.[6] and Storms et al.[20] preferred to utilize montelukast, which has been used safely for many years, as a preventive single dose. The maximal plasma concentration of montelukast is reached between three and four hours after administration.[6,11,12] This led us to believe that taking the medication an hour before surgery would allow the medication to reach its maximal plasma concentration.[9]

Although the outcomes of this randomized clinical trial are promising, they do have some drawbacks. The limitation of the study was that the sample size was small.

CONCLUSION

Comparable studies using a multicenter population should be carried out across the country because this study was conducted through a limited population. Montelukast’s effect was evaluated in the current study within the first 24 hours following surgery; however, it may be advantageous to analyze this preventive effect over a longer timeframe, such as the first 72 hours following surgery. Additionally, we advise looking into the results of postoperative pain intensity following the administration of different doses of montelukast. The postoperative discomfort from other craniofacial operations can be measured for this effect. It can be said that preoperative administration of montelukast helps to lessen pain after surgery in bimaxillary orthognathic surgery. For the results to be more reliable, additional research is required.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.